Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

GlaxoSmithKline120 enrolled

Overview

To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Infections, Streptococcal

Interventions

Pneumococcal vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 11 MonthsMax age: 14 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion: * healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine. Exclusion: * children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs; * children having received any additional pneumococcal vaccine than in the primary study; * children with any disease that affect the immune system and history of seizures and/or allergic disease.

Locations (30)

Outcomes

Primary Outcomes

Antibody concentrations against pneumococcal serotypes 1 month post-booster

Secondary Outcomes

Immunogenicity pre and post-booster and safety (follow up of SAEs)

Data from ClinicalTrials.gov

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Marbach, Baden-Wurttemberg, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Tutzing, Bavaria, Germany

GSK Investigational Site

Wiesbaden, Hesse, Germany

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Waren, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, Germany

GSK Investigational Site

Erkrath, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

...and 20 more locations